Cleared Traditional

K903834 - N. M. BEALE COMPANY VU-THRU WATER BOTTLE
(FDA 510(k) Clearance)

K903834 · N.M. Beale Co., Inc. · Gastroenterology & Urology

Sep 1990

Decision

34d

Days

Class 2

Risk

K903834 is an FDA 510(k) clearance for the N. M. BEALE COMPANY VU-THRU WATER BOTTLE. This device is classified as a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX).

Submitted by N.M. Beale Co., Inc. (Weymouth, US). The FDA issued a Cleared decision on September 24, 1990, 34 days after receiving the submission on August 21, 1990.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures..

Submission Details

510(k) Number	K903834 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1990
Decision Date	September 24, 1990
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	OCX — Endoscopic Irrigation/suction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.